"You cannot responsibly introduce products into a Medicare population when their chemistry is not fully defined and their safety cannot be established. This is not a policy debate-it's a scientific one. MMJ followed the FDA pathway because patients deserve certainty, not guesswork." stated Duane Boise, CEO MMJ International Holdings.
WASHINGTON, D.C. / ACCESS Newswire / May 5, 2026 / A federal judge is now deciding whether to halt a controversial Medicare linked hemp, marijuana CBD program-just as Europe's top scientific authority has delivered a stunning conclusion:
It cannot confirm that a leading CBD product is safe for human consumption.
The finding, issued by the European Food Safety Authority (EFSA)-widely regarded as the European equivalent of the U.S. Food and Drug Administration directly challenges the scientific foundation of the U.S. Centers for Medicare & Medicaid Services (CMS) Substance Access Beneficiary Engagement Incentive (BEI) program.
THE SCIENCE JUST COLLAPSED
In a March 2026 ruling, EFSA evaluated a hemp-derived CBD extract submitted by Charlotte's Web, one of the most established cannabinoid companies in the United States.
After full scientific review, EFSA found:
20-30% of the product remains chemically uncharacterized
No toxicology studies on the actual product being marketed
No human clinical safety data
Stability testing conducted on a different formulation
Unknown allergenic risk
Final determination:
AT THE SAME TIME: CMS MOVES INTO THE MEDICARE POPULATION
While global regulators cannot confirm safety, CMS has already launched the BEI program-allowing providers to:
Discuss hemp, marijuana-derived cannabinoid products
Furnish them in Medicare linked care settings
This targets Americans over 65, a population that is:
Managing multiple prescriptions
More vulnerable to adverse drug interactions
Largely excluded from cannabinoid safety trials
THE CRITICAL QUESTION: WHAT EXACTLY IS BEING GIVEN TO PATIENTS?
EFSA's findings expose a fundamental problem:
If a leading CBD product cannot be fully defined... what about the rest of the market?
Because BEI suppliers have not submitted:
FDA Investigational New Drug (IND) applications
Chemistry, Manufacturing, and Controls (CMC) validation
Standardized dosing data
Human safety studies
Stability testing on final products
They have not even attempted to meet the FDA standards that failed in Europe
The U.S. District Court for the District of Columbia is weighing whether to halt the BEI program in:
Smart Approaches to Marijuana (SAM) et al. v. Kennedy
(Case No. 1:26-cv-01081)
At stake:
Whether CMS bypassed Administrative Procedure Act requirements
Whether it introduced products without established safety standards
Whether it created a parallel system outside FDA oversight
THE SCIENCE GAP - AND WHY IT MATTERS
This is not about cannabis policy.
This is about whether medicine is defined by science or by assumption.
FDA Standard | BEI Reality |
Fully characterized drug | Partially unknown composition |
Reproducible dosing | Variable botanical mixtures |
Human safety proven | Not established |
Stability verified | Unknown |
DUANE BOISE, CEO - MMJ INTERNATIONAL HOLDINGS
"If the world's leading safety authority cannot confirm what is in a hemp, marijuana derived CBD product or whether it is safe, there is no scientific basis to introduce it into Medicare care. MMJ followed the FDA pathway because patients deserve precision, reproducibility, and accountability-not uncertainty. The BEI program introduces uncertainty into the most vulnerable population."
WHY THIS IS A TURNING POINT
If BEI continues:
Physicians are forced to evaluate non-standardized products
Patients may receive chemically undefined mixtures
Clinical drug development is undermined
Investor confidence in regulated medicine is damaged
The line between medicine and supplement collapses
GLOBAL REGULATORS VS. U.S. POLICY
Europe demanded proof-and rejected the product.
The United States is now being asked to decide:
Should access come before evidence?
Or should science come first?
THE BOTTOM LINE
If safety cannot be established...
why is the product being introduced into Medicare?
ABOUT MMJ INTERNATIONAL HOLDINGS
MMJ International Holdings, Inc. is a U.S.-based biopharmaceutical company developing FDA compliant cannabinoid therapies for Huntington's disease and multiple sclerosis. Through its subsidiaries MMJ BioPharma Cultivation and MMJ BioPharma Labs, MMJ is advancing standardized, pharmaceutical grade cannabinoid drug products under the FDA's botanical drug development framework.
Madison Hisey
MHisey@mmjih.com
203-231-85832
SOURCE: MMJ International Holdings
View the original press release on ACCESS Newswire
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